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Summary

please see my linkedin profile to learn about my background.

i am interested to use my yearlong experience in Medical Sciences and my background in Medicine to contribute or to set-out Clinical, medical or scientific development strategies for Medical Devices in Therapeutic Areas of common or rare diseases, to fill in Clinical, medical, r&d management functions; 

 

 

Experiences

Current Experience

  • Clinical and Scientific Affairs Manager (Interim)

    Eindhoven, Netherlands
    Since July 2015

    Planning, organizing and managing international Clinical safety and efficacy studies with with high-Energy output cosmetic devices for home-use;

    claim-substantiation studies; pmcf studies; 

    recruitment of and cooperation with cros; 

    part of a Product Development teams; 

    therapeutic area: Dermatology

    Planning, organizing and managing international clinical safety and efficacy studies with with high-energy output cosmetic devices for home-use;

    Claim-substantiation studies; PMCF studies; 

    Recruitment of and cooperation with CROs; 

    Part of a product development teams; 

    Therapeutic area: Dermatology

Past Experience

  • Clinical Project Leader Brussels, Belgium

    September 2007 --- March 2014

    Clinical Trial manager for clinical studies with Medical Device in therapeutic apheresis bringing to market the next gold standard apheresis device for market Leader terumobct (former cobe instruments).

    study types: first-in-patient studies, first-to-market-studies, allogeneic donor studies, pms, pmcf / sponsor-initiated studies and iit 

    Therapeutic Areas: rare diseases, blood cancers, immune diseases; 

    methods: blood Cell exchange/collection/depletion; pbsc collection; preparation of bm transplants; 

    covered all aspects of studies inclusive study design, science)" rel="nofollow">Protocol writing, crf design, ec / irb submissions, data and safety monitoring, Report Writing, Data Management support, Data Analysis support, scientific support; managed and trained CRA´s; reported into cross-functional international teams; 

Personality

Self Assessment :
Analytical thinkingApproachabilityAttention to detailCommunicativeCollaborationCompetitivenessCreative thinkingCritical thinkingDiligenceEfficiencyInnovative thinkingIndependenceProblem solvingResiliencyResult OrientedStrategic thinkingTrust

Education

  • Doctorate in Medical Sciences from KU Leuven in 1996
  • Master in Medicine, Biophysics from The Russian State Medical University, Moscow in 1990

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
Dutch
Full Proficiency
English
Full Proficiency
Russian
Professional Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Medical Advisor Medical Manager R&D manager
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    Permanent position :    80%-100% FTE
  • International:
    Yes

Area / Region

België

Others

Driving License
  • Yes

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